Citeline Podcasts

Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed (:32), an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees (9:08), and Japan’s PMDA opening an office in Washington D.C. (16:19).

More On These Topics From The Pink Sheet

Amylyx’s Relyvrio Withdrawal May Trigger More Public Pledges Based On Confirmatory Trial Data: https://pink.citeline.com/PS150060/Amylyxs-Relyvrio-Withdrawal-May-Trigger-More-Public-Pledges-Based-On-Confirmatory-Trial-Data

US FDA Envisions Advisory Committees For Allergy, Asthma Biomarkers With ‘Real Impact’: https://pink.citeline.com/PS149915/US-FDA-Envisions-Advisory-Committees-For-Allergy-Asthma-Biomarkers-With-Real-Impact

Breaking Barriers: Japan's PMDA To Open First Global Office, In D.C.: https://pink.citeline.com/PS150044/Breaking-Barriers-Japans-PMDA-To-Open-First-Global-Office-In-DC

In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to industry professionals at the Healthcare Information and Management Systems Society (HIMSS) 2024 conference about what they enjoy about the annual gathering and what excites them for the future.

기술 수요와 공급의 '불균형' 속에서 국내 ADC 업체들은 생태계를 발전시키려 노력하고 있습니다.  Scrip의 정두영 피노바이오 대표 인터뷰기사를 요약한 내용입니다.

https://scrip.citeline.com/SC149716/How-Pinotbio-Is-Helping-Build-Koreas-ADC-Ecosystem

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: Merck & Co progresses cardiovascular strategy; Novo purchase builds heart failure presence; CRL setbacks for Regeneron; ITF faces challenging Duchenne field; and AbbVie needs to freshen up.

https://scrip.citeline.com/SC150030/Quick-Listen-Scrips-Five-MustKnow-Things

In this episode, HBW Insight’s Europe and US editors Tom Gallen and Malcolm Spicer bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago, Kenvue, soon to celebrate its first anniversary as a new company; Sanofi, which has announced it will be exiting the OTC market by divesting its OTC business and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the possible advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.

Flora and Ian are joined by Datamonitor’s financial analyst Abby, who discusses the Inflation Reduction Act and drug pricing trends in the US.

Other platforms (in addition to SoundCloud):​

Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​

Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz​

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TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/​

​Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67

Audio roundup of selected biopharma industry content from Scrip over the past business week. In this episode: another big deal in radiopharmaceuticals; BioNTech’s ADC pipeline; China CDMOs embrace uncertain future; at look at the rivals in MASH; and industry views on how AI might be transformative.

https://scrip.citeline.com/SC150008/Quick-Listen-Scrips-Five-MustKnow-Things

Pink Sheet reporters and editor discuss the upcoming US Supreme Court arguments on mifepristone access (:34), the SCOTUS reaction to the fight against misinformation (18:28), and the FDA’s Oncologic Drugs Advisory Committee going against three negative product reviews (31:23).

More On These Topics From The Pink Sheet

Mifepristone Supporters Highlight Voter Trust In FDA Decisions Ahead Of Supreme Court Arguments: https://pink.citeline.com/PS149998/Mifepristone-Supporters-Highlight-Voter-Trust-In-FDA-Decisions-Ahead-Of-Supreme-Court-Arguments

US FDA’s Anti-Misinformation Campaigns Look Safer After Supreme Court Oral Arguments: https://pink.citeline.com/PS149985/US-FDAs-Anti-Misinformation-Campaigns-Look-Safer-After-Supreme-Court-Oral-Arguments

The Dog That Didn’t Bark: ODAC Gives Nod To Three Products Despite Negative FDA Reviews: https://pink.citeline.com/PS149961/The-Dog-That-Didnt-Bark-ODAC-Gives-Nod-To-Three-Products-Despite-Negative-FDA-Reviews

Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts: https://pink.citeline.com/PS149995/Eye-On-ODAC-Former-Members-FDAs-Pazdur-Talk-PreMeeting-Mindsets-Impact-Of-Sponsors-Experts

Guest speaker Kevin Duan joins Brian Yang and Dexter Yan to discuss the proposed US BIOSECURE Act, the US FDA's approval of a China-origin anti-PD-1 drug and the latest developments in the antibody-drug conjugate area.

Listen to the podcast via the player below:

Medtech Insight articles addressing topics discussed in this episode:

In Five Years, People Will Navigate Their Health Care With An AI-Advisor – Verily’s Andrew Trister

Verily’s Andrew Trister On Uniting The Pieces To Create Personalized Health, Equity

European Parliament Adopts AI Act, But Success Hangs On The AI Office

AI Clinical Summarization Tools Sit In 'Regulatory Grey Area', Experts Warn